October 2019

21 CFR 820, ISO 13485:2016 and MDR – Are you prepared for the changes ahead?

By |2019-10-24T15:59:04+02:00October 24th, 2019|Medical Device, Non classé, Quality|

Medical device manufacturing and marketing in the U.S.A. is regulated by the FDA. Medical device manufacturers must register with the FDA and produce their products with a Quality System that meets the FDA Quality System Regulation and more precisely with the 21 CFR 820. Compliance with regulations is crucial and requires an investment of both […]

March 2019

ISO 9001 versus ISO 13485

By |2021-06-30T23:28:31+02:00March 7th, 2019|General, Medical Device, Quality|

ISO 9001 versus ISO 13485 – What are the differences and which certification is best adapted to medical devices manufacturers?

Developing products with highest quality standards is essential for medical device manufacturers. Having been certified to both ISO 9001 and ISO 13485 for the past decade, Valtronic and quality manufacturing are long time companions. However, is […]

April 2016

The Document Control Police Are Here!

By |2019-06-26T07:57:58+02:00April 21st, 2016|Quality|

One would quickly describe the position of Document Control as the “police” of an organization that maintains tight jurisdiction and follows strict guidelines to controlling all aspects of internal documentation.

So let’s define what Document Control really does in an and contract manufacturing world.
  • Collects, maintains and distributes all documents necessary to define product configuration and […]

March 2016

Top Two Things That Make an Effective Quality Management System

By |2019-06-17T08:14:44+02:00March 10th, 2016|Quality|

As I am working on entering first pass yield data into a system I have created for Valtronic, I am reminded of past businesses that I have worked for. In those positions, the Quality system (or Quality Management System – QMS) was a key identification tool to help businesses and their customers thrive. The QMS systems […]

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